Multiple SclerosisNCT00338741
Rebif® Pregnancy Registry
An observational study of Multiple Sclerosis, run by EMD Serono at 1 site in United States.
Trial summary
The objective for establishing the Rebif® Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif® during their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Feb 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant MS patients
Who may be able to join
- Rebif®-Exposed Group
- For prospective follow-up, women in the United States and Canada shall be eligible for enrollment in the Rebif® Pregnancy Registry as subjects if:
- They are pregnant.
- They received Rebif® for treatment of Multiple Sclerosis (MS) within one week before or at any time after conception.
- The outcome of pregnancy has not been previously evaluated by any diagnostic method such as ultrasound. However, since ultrasound techniques are often used at early stages to confirm pregnancy, patients who have been evaluated by ultrasound for the purpose of confirming the pregnancy shall be eligible for enrollment in the Registry. The use of ultrasound and any inferences that could be made about the outcome of the patient's pregnancy will be reported on the case report form. Following enrollment in the Registry, diagnostic tests may be performed at any time during the pregnancy.
- They have not used Copaxone® for treatment of MS within the previous three months and have not been exposed to Novantrone®, Imuran®, Cytoxan®, Tysabri® or methotrexate at any time.
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- Patients who have been exposed to an investigational product or procedure within the previous year may be enrolled at the discretion of the Medical Director. The enrolling physician should contact Serono's authorized agent, a company called Registrat, at 866-997-3243 to request a review of each patient's situation.
- Interferon-beta -Not Exposed Comparison Group
- Women with MS who live in the United States or Canada will be eligible for the comparison group if:
- They are pregnant.
- The outcome of pregnancy has not been previously evaluated by any diagnostic method such as ultrasound. However, since ultrasound techniques are often used at early stages to confirm pregnancy, patients who have been evaluated by ultrasound for the purpose of confirming the pregnancy shall be eligible for enrollment in the Registry. The use of ultrasound and any inferences that could be made about the outcome of the patient's pregnancy will be reported on the case report form. Following enrollment in the Registry, diagnostic tests may be performed at any time during the pregnancy.
- They have not received any interferon-beta within 90 days of conception.
- They have not used Copaxone® for treatment of MS within the previous three months and have not been exposed to Novantrone®, Imuran®, Cytoxan®, Tysabri® or methotrexate at any time.
- Patients who have been exposed to an investigational product or procedure within the previous year may be enrolled at the discretion of the Medical Director. The enrolling physician should contact Serono's authorized agent, a company called Registrat, at 866-997-3243 to request a review of each patient's situation.
Who cannot join
- Not Applicable
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Medical Information Office
Rockland, Massachusetts, 02370
About this study
The objective for establishing the Rebif® Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif® during their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed pregnancies. This rate will be compared with the rate of spontaneous abortions in patients with Multiple Sclerosis (MS) whose pregnancies were not exposed to any interferon-beta in a manner consistent with the FDA August 2002 Guidance for Industry: Establishing Pregnancy Exposure Registries
Read the detailed description
This study is a post-approval commitment to follow Rebif®-exposed pregnancies and compare them to non-Rebif® exposed pregnancies to evaluate rate of spontaneous abortion, fetal abnormality or pregnancy related health outcomes.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Rebif exposed pregnancies | |
| 2 | Non-Rebif exposed pregnancies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Abortion
Number of participants having spontaneous abortion
Measured: Up to 9 months
Secondary outcomes (1)
Fetal Death/Stillbirth
Fetal death/stillbirth
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startDec 2002
- Primary completionOct 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Dan Mikol, MD, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338741
- Sponsor's protocol ID
- 23888
- Status last verified
- Aug 2011
- First submitted
- 16 Jun 2006
- Last updated
- 5 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebif® Pregnancy Registry
- ClinicalTrials.gov ID
- NCT00338741
- Acronym / sponsor ID
- 23888
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Dec 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Posted 2 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective for establishing the Rebif® Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif® during their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed pregnancies. This rate will be compared with the rate of spontaneous abortions in patients with Multiple Sclerosis (MS) whose pregnancies were not exposed to any interferon-beta in a manner consistent with the FDA August 2002 Guidance for Industry: Establishing Pregnancy Exposure Registries
Detailed description
This study is a post-approval commitment to follow Rebif®-exposed pregnancies and compare them to non-Rebif® exposed pregnancies to evaluate rate of spontaneous abortion, fetal abnormality or pregnancy related health outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Rebif exposed pregnancies |
| 2 | – | –Non-Rebif exposed pregnancies |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant MS patients
Key inclusion criteria (14 listed)
- Rebif®-Exposed Group
- For prospective follow-up, women in the United States and Canada shall be eligible for enrollment in the Rebif® Pregnancy Registry as subjects if:
- They are pregnant.
- They received Rebif® for treatment of Multiple Sclerosis (MS) within one week before or at any time after conception.
- The outcome of pregnancy has not been previously evaluated by any diagnostic method such as ultrasound. However, since ultrasound techniques are often used at early stages to confirm pregnancy, patients who have been evaluated by ultrasound for the purpose of confirming the pregnancy shall be eligible for enrollment in the Registry. The use of ultrasound and any inferences that could be made about the outcome of the patient's pregnancy will be reported on the case report form. Following enrollment in the Registry, diagnostic tests may be performed at any time during the pregnancy.
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spontaneous Abortion
Time frame: Up to 9 months
Number of participants having spontaneous abortion
1 secondary outcome
Fetal Death/Stillbirth
Time frame: Up to 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Mikol, MD study director
EMD Serono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by EMD Serono at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Abortion (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2013.